India Set To Become Major Manufacturing Hub Of Sputnik V COVID Vaccine – Regulatory Approval Comes As COVID Cases Spike
COVID-19 cases in India have skyrocketed by 70% in the past week

India has greenlighted Russia’s Sputnik V vaccine for emergency use following a severe shortage of vaccines against the coronavirus and a massive spike in cases, and is now poised to become one of the world’s largest manufacturing hubs for the vaccine with 50 million doses produced by July. 

India’s aproval of a third COVID vaccine comes as the country recorded over 185,000 new cases of COVID-19 on Tuesday – which is almost double that at the height of the first wave seen last September – and represents a 70% increase in cases over just the past week. 

So far, India has administered 100 million vaccine doses to its population of 1.4 billion people. These include Covishield, the lstraZeneca-Oxford vaccine being manufactured locally by the Serum Institute, as well as the indigenous Covaxin, developed by India’s Council for Medical Research, and manufactured by Hyderabad-based Bharat Biotech.

Sputnik V, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials  – nearly on par with the highest-performing mRNA vaccines produced by Moderna and Pfizer/BioNTech. It is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts, and rather requiring ultra-deep freeze, can be stored in conventional refrigerators for months.

Sputnik V costs $10 per dose and can be stored in conventional refrigerators, making it ideal for low-income settings

India Plans To Produce 50 Million Doses of Sputnik By July

Through new partnerships and “working capital” investments with five vaccine manufacturers, India should have the capacity to produce over 50 million doses of Sputnik by July, announced the CEO of the RDIF on Tuesday.

“We have announced partnerships with five of the largest production companies in India,” said Kirill Dmitriev, noting that improved manufacturing capacity will help speed up India’s vaccination drive. “We will be announcing a few more.”

The new partnerships, sealed with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech, will help India become the world’s “largest production hub” of Sputnik, said Dmitriev, who called it a “Russian-Indian” vaccine.

“We believe Russia and India will be the largest production hubs [of Sputnik V] in the world,” said Dmitriev. “We actually think of this [Sputnik-V] as Russian-Indian vaccine because lots of production will be done in India,” said Dmitriev at a virtual press conference.

In recent months, the RDIF has partnered with a dozen countries to manufacture Sputnik, including China, Kazakhstan and South Korea. In total, it aims to produce 850 million doses of the vaccine a year.

Meanwhile, as India begins to ramp up domestic production of Sputnik V, the country may see its first deliveries of the vaccine from other RDIF production centers abroad within the next three weeks, Dmitriev told India Today. 

Dmitriev also said that RDIF is in negotiations with the Indian government to set a differential price for Sputnik V for the private and public health sectors.

India Will Fast-Track Approval of Foreign Vaccines 

In another effort to expedite the country’s massive vaccination drive, the Indian government also announced that it will fast-track foreign vaccines that have been approved by “credible” regulatory authorities – such as the US Food and Drug Administration, the European Medicines Agency, or the WHO’s Emergency Use Listing.

India’s health secretary Rajesh Bhushan said this will speed up India’s vaccination drive by overcoming the need for local clinical trials, the so-called “bridging trials”, which serve to ensure that foreign vaccines cater to the Indian context. 

“The pre-condition of having bridging clinical trials for a foreign vaccine before emergency use authorisation has been done away with and has been replaced with a parallel bridging trial post-approval,” he said in a press release.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use,” said the press release.

Image Credits: RDIF, WHO.

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